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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K254180

510(k) cleared

PerfusiX-Imaging

LIMIS Development B.V. · Jul 24, 2026 · K254180

FDA cleared the PerfusiX-Imaging from LIMIS Development B.V. on Jul 24, 2026 under K254180, a traditional 510(k). The device falls under product code OWN, Confocal Optical Imaging, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 23, 2025. The decision came 213 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for LIMIS Development B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254180?

K254180 is the FDA 510(k) for PerfusiX-Imaging, submitted by LIMIS Development B.V.. FDA's decision date was Jul 24, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the PerfusiX-Imaging?

LIMIS Development B.V., based in Leeuwarden, is the applicant of record for K254180.

How long did the K254180 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Jul 24, 2026, 213 days later.

← All decisions in July 2026